Dental AnxietyNCT04967300
Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments
An observational study of Dental Anxiety, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
Dental anxiety is defined as the fear of terrible events during dental treatment and the loss of control.Anxiety may be related to adaptation of the patient to external factors in environment, so the adaptation of the pediatric patient to the stimuli in the dental environment may affect the level of anxiety.The aim of… Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Dental treatment
- Type of treatment
- Surgery or procedure
- How many people
- 224 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 30 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 224 children aged 5-8 years who needed at least two restorative dental treatments of the mandibular first primary molar were included in the study. As the inclusion criteria, children with no mental disorders, with no past dental experience, hospitalization or invasive medical treatments, and no pain or symptom in their oral health. All included children and parents had to spoken and understood the Turkish language. Patients with chronic systemic illnesses that may affect the blood pressure or heart rate of a child were excluded from the study. Only children who required multiple-visit treatments were taken into consideration.
Who may be able to join
- Children aged 5-8 years
- Children who need at least two restorative dental treatments of the mandibular first primary molar
Who cannot join
- Chronic systemic illnesses
- Dental experience
- Mental disorders
- Invasive medical treatments
- Hospitalization
- Oral health problems with a painful history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments: A Retrospective Observational Cohort Study
Dental anxiety is defined as the fear of terrible events during dental treatment and the loss of control.Anxiety may be related to adaptation of the patient to external factors in environment, so the adaptation of the pediatric patient to the stimuli in the dental environment may affect the level of anxiety.The aim of the this study was to evaluate the relationship between sequential visits in dental treatments and dental anxiety levels of pediatric patients with anxiety scales and physiological measurements.
Read the detailed description
A total of 224 children aged 5-8 years who needed at least two restorative dental treatment of the mandibular first primary molar were included in the study.
In each sessions the Wong-Baker FACES Pain Rating Scale (W-BFRS) was used to evaluate the dental anxiety before and after the treatment.
The Modified Corah's Dental Anxiety Scale (MDAS) was used as a dental anxiety measurement method.
A portable finger pulse oximeter (Nellcor™ PMN10, Medtronic Corp. MN, USA) was used to measure the heart rate.
Data were statistically analyzed with the help of the Statistical Package for Social Sciences statistical software (SPSS 18.0), considering a 5% significance level. Nonparametric tests were used. Normality assumption was evaluated with the Kolmogorov Smirnov test. The association between two groups was analyzed by Wilcoxon Signed Rank Test.
- Conditions
- Dental Anxiety
- Being tested
- Dental treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental treatmentProcedure or surgery
bilateral restorative treatment on the mandibular primary first molars
| Study group | Role | What they receive |
|---|---|---|
| First Visit | Children who visit dentist at first time Receives: Procedure: Dental treatment | |
| Second Visit | Children who visit dentist at second time Receives: Procedure: Dental treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental anxiety
The Modified Corah's Dental Anxiety Scale minimum 5 points maximum 25 points more than 15 points means patient have dental axiety .Higher points mean worse outcome
Measured: at the first dental visit, during two weeks
Dental anxiety
The Modified Corah's Dental Anxiety Scale minimum 5 points maximum 25 points more than 15 points means patient have dental axiety .Higher points mean worse outcome
Measured: at the second dental visit, during two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Mar 2020
- Primary completion30 Jul 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurcan Kutluer Karaca, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967300
- Sponsor's protocol ID
- Erzincan Binali Yıldırım U.
- Status last verified
- Jul 2021
- First submitted
- 8 Jun 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments: A Retrospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04967300
- Acronym / sponsor ID
- Erzincan Binali Yıldırım U.
- Conditions
- Dental Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dental anxiety is defined as the fear of terrible events during dental treatment and the loss of control.Anxiety may be related to adaptation of the patient to external factors in environment, so the adaptation of the pediatric patient to the stimuli in the dental environment may affect the level of anxiety.The aim of the this study was to evaluate the relationship between sequential visits in dental treatments and dental anxiety levels of pediatric patients with anxiety scales and physiological measurements.
Detailed description
A total of 224 children aged 5-8 years who needed at least two restorative dental treatment of the mandibular first primary molar were included in the study.
In each sessions the Wong-Baker FACES Pain Rating Scale (W-BFRS) was used to evaluate the dental anxiety before and after the treatment.
The Modified Corah's Dental Anxiety Scale (MDAS) was used as a dental anxiety measurement method.
A portable finger pulse oximeter (Nellcor™ PMN10, Medtronic Corp. MN, USA) was used to measure the heart rate.
Data were statistically analyzed with the help of the Statistical Package for Social Sciences statistical software (SPSS 18.0), considering a 5% significance level. Nonparametric tests were used. Normality assumption was evaluated with the Kolmogorov Smirnov test. The association between two groups was analyzed by Wilcoxon Signed Rank Test.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Visit | – | Procedure: Dental treatmentChildren who visit dentist at first time |
| Second Visit | – | Procedure: Dental treatmentChildren who visit dentist at second time |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 224 children aged 5-8 years who needed at least two restorative dental treatments of the mandibular first primary molar were included in the study. As the inclusion criteria, children with no mental disorders, with no past dental experience, hospitalization or invasive medical treatments, and no pain or symptom in their oral health. All included children and parents had to spoken and understood the Turkish language. Patients with chronic systemic illnesses that may affect the blood pressure or heart rate of a child were excluded from the study. Only children who required multiple-visit treatments were taken into consideration.
Key inclusion criteria (2 listed)
- Children aged 5-8 years
- Children who need at least two restorative dental treatments of the mandibular first primary molar
Key exclusion criteria (6 listed)
- Chronic systemic illnesses
- Dental experience
- Mental disorders
- Invasive medical treatments
- Hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental treatmentbilateral restorative treatment on the mandibular primary first molars | Procedure or surgery | First Visit, Second Visit |
Primary outcome
Dental anxiety
Time frame: at the first dental visit, during two weeks
The Modified Corah's Dental Anxiety Scale minimum 5 points maximum 25 points more than 15 points means patient have dental axiety .Higher points mean worse outcome
Dental anxiety
Time frame: at the second dental visit, during two weeks
The Modified Corah's Dental Anxiety Scale minimum 5 points maximum 25 points more than 15 points means patient have dental axiety .Higher points mean worse outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Anxiety, run by Erzincan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental anxiety (time frame: at the first dental visit, during two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.